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Purpose: We report 5-year safety and efficacy outcomes of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia and large-volume prostate glands. Materials and Methods: A total of 101 men with moderate to severe benign prostatic hyperplasia symptoms and prostate volumes between 80 and 150 mL underwent a robotic-assisted Aquablation procedure in a prospective multicenter international trial (NCT03123250). Herein we report the final 5-year results. Results: The study successfully met its safety and efficacy performance goal, which was based upon transurethral resection of the prostate outcomes typically done in smaller prostates, at 3 months. Mean prostate volume was 107 mL (range 80-150) at baseline. Patient symptoms showed a significant improvement where the mean (SD) International Prostate Symptom Score of 22.6 (6.4) at baseline to 6.8 (4.6) at 5 years, resulting in a change score of 15.9 (7.7, P < .001). Uroflowmetry measurements also demonstrated improvement where the mean maximum urinary flow rate increased from 8.6 (SD 3.4) to 17.1 (9.8) mL/s at 5 years, resulting in a change score of 9.2 (11.1) mL/s at 5 years (P < .001). A regression analysis evaluating change in PSA as a function of baseline PSA across all time points out to 5 years resulted in a 50% reduction. A prespecified subgroup analysis using a baseline prostate volume cutoff of 100 mL showed no difference in efficacy outcomes through 5 years. Freedom from a secondary benign prostatic hyperplasia procedure at 5 years was 96.3% based on Kaplan-Meier. Conclusions: At 5-years of prospective follow-up, the Aquablation procedure was shown to be safe with durable efficacy and low rates of retreatment in men with large prostates (80-150 mL). [ABSTRACT FROM AUTHOR]

Background: Patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) have limited treatment options. The immune cell-activating interleukin-15 (IL-15) superagonist Nogapendekin alfa inbakicept (NAI), also known as N-803, may act synergistically with BCG to elicit durable complete responses (CRs) in this patient population. Methods: In this open-label, multicenter study, patients with BCG-unresponsive bladder carcinoma in situ (CIS) with or without Ta/T1 papillary disease were treated with intravesical NAI plus BCG (cohort A) or NAI alone (cohort C). Patients with BCG-unresponsive high-grade Ta/T1 papillary NMIBC also received NAI plus BCG (cohort B). The primary end point was the incidence of CR at the 3- or 6-month assessment visit for cohorts A and C, and the disease-free survival (DFS) rate at 12 months for cohort B. Durability, cystectomy avoidance, progression-free survival, disease-specific survival (DSS), and overall survival were secondary end points for cohort A. Results: In cohort A, CR was achieved in 58 (71%) of 82 patients (95% confidence interval [CI]=59.6 to 80.3; median follow-up, 23.9 months), with a median duration of 26.6 months (95% CI=9.9 months to [upper bound not reached]). At 24 months in patients with CR, the Kaplan-Meier estimated probability of avoiding cystectomy and of DSS was 89.2% and 100%, respectively. In cohort B (n=72), the Kaplan-Meier estimated DFS rate was 55.4% (95% CI=42.0% to 66.8%) at 12 months, with median DFS of 19.3 months (95% CI=7.4 months to [upper bound not reached]). Most treatment-emergent adverse events for patients receiving BCG plus NAI were grade 1 to 2 (86%); three grade 3 immune-related treatment-emergent adverse events occurred. Conclusions: In patients with BCG-unresponsive bladder carcinoma in situ and papillary NMIBC treated with BCG and the novel agent NAI, CRs were achieved with a persistence of effect, cystectomy avoidance, and 100% bladder cancer-specific survival at 24 months. The study is ongoing, with an estimated target enrollment of 200 participants (Funded by ImmunityBio.) [ABSTRACT FROM AUTHOR]

Objective: To present 6‐month safety and effectiveness data from a multicentre prospective study of aquablation in men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH) with prostate volumes between 80 and 150 mL. Methods: Between September and December 2017, 101 men with LUTSattributable to BPHwere prospectively enrolled at 16 centres in Canada and the USA. Results: The mean prostate volume was 107 mL. The mean length of hospital stay after the aquablation procedure was 1.6 days (range: same day to 6 days). The primary safety endpoint (Clavien–Dindo grade 2 or higher or any grade 1 event resulting in persistent disability) at 3 months occurred in 45.5% of men, which met the study design goal of < 65% (P < 0.001). At 6 months, 22% of the patients had experienced a Clavien–Dindo grade 2, 14% a grade 3 and 5% a grade 4 adverse event. Bleeding complications requiring intervention and/or transfusion were recorded in eight patients prior to discharge and in six patients after discharge. The mean International Prostate Symptom Score improved from 23.2 ± 6.3 at baseline to 6.7 ± 5.1 at 3 months, meeting the study's primary efficacy endpoint goal (P < 0.001). The maximum urinary flow rate increased from 8.7 to 18.8 mL/s (P < 0.001) and post‐void residual urine volume decreased from 131 at baseline to 47 at 6 months (P < 0.0001). At 6 months, prostate‐specific antigen concentration reduced from 7.1 ± 5.9 ng/mL at baseline to 4.0 ± 3.9 ng/mL, a 44% reduction. Conclusions: Aquablation is safe and effective in treating men with larger prostates (80–150 mL), without significant increase in procedure or resection time. [ABSTRACT FROM AUTHOR]

Objective: To test the hypothesis that benign prostatic hyperplasia (BPH) robotic surgery with aquablation would have a more pronounced benefit in certain patient subgroups, such as men with more challenging anatomies (e.g. large prostates, large middle lobes) and men with moderate BPH. Methods: We conducted prespecified and post hoc exploratory subgroup analyses from a double‐blind, multicentre prospective randomized controlled trial that compared transurethral resection of the prostate (TURP) using either standard electrocautery vs surgery using robotic waterjet (aquablation) to determine whether certain baseline factors predicted more marked responses after aquablation as compared with TURP. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien–Dindo persistent grade 1 or grade ≥2 surgical complications. Results: For men with larger prostates (50–80 g), the mean IPSS reduction was four points greater after aquablation than after TURP (P = 0.001), a larger difference than the overall result (1.8 points; P = 0.135). Similarly, the primary safety endpoint difference (20% vs 46% [26% difference]; P = 0.008) was greater for men with large prostate compared with the overall result (26% vs 42% [16% difference]; P = 0.015). Postoperative anejaculation was also less common after aquablation compared with TURP in sexually active men with large prostates (2% vs 41%; P < 0.001) vs the overall results (10% vs 36%; P < 0.001). Exploratory analysis showed larger IPSS changes after aquablation in men with enlarged middle lobes, men with severe middle lobe obstruction, men with a low baseline maximum urinary flow rate, and men with elevated (>100) post‐void residual urine volume. Conclusions: In men with moderate‐to‐severe lower urinary tract symptoms attributable to BPH and larger, more complex prostates, aquablation was associated with both superior symptom score improvements and a superior safety profile, with a significantly lower rate of postoperative anejaculation. The standardized, robotically executed, surgical approach with aquablation may overcome the increased outcome variability in more complex anatomy, resulting in superior symptom score reduction. [ABSTRACT FROM AUTHOR]

Objectives: To present early safety and feasibility data from a multicentre prospective study (WATER II) of aquablation in the treatment of symptomatic men with large‐volume benign prostatic hyperplasia (BPH). Methods: Between September and December 2017, 101 men with moderate‐to‐severe BPH symptoms and prostate volume of 80–150 mL underwent aquablation in a prospective multicentre international clinical trial. Baseline demographics and standardized postoperative management variables were carefully recorded in a central independently monitored database. Surgeons answered analogue scale questionnaires on intra‐operative technical factors and postoperative management. Adverse events up to 1 month were adjudicated by an independent clinical events committee. Results: The mean (range) prostate volume was 107 (80–150) mL. The mean (range) operating time was 37 (15–97) min and aquablation resection time was 8 (3–15) min. Adequate adenoma resection was achieved with a single pass in 34 patients and with additional passes in 67 patients (mean 1.8 treatment passes), all in a single operating session. Haemostasis was achieved using either a Foley balloon catheter placed in the bladder under traction (n = 98, mean duration 18 h) or direct tamponade using a balloon inflated in the prostate fossa (n = 3, mean duration 15 h). No patient required electrocautery for haemostasis at the time of the primary procedure. The mean length of stay after the procedure was 1.6 days (range same day to 6 days). The Clavien–Dindo grade ≥2 event rate observed at 1 month was 29.7%. Bleeding complications were recorded in 10 patients (9.9%) during the index procedure hospitalization prior to discharge, and included six (5.9%) peri‐operative transfusions. Conclusions: Aquablation is feasible and safe in treating men with men with large prostates (80–150 mL). The 6‐month efficacy data are being accrued and will be presented in future publications (ClinicalTrials.gov number, NCT03123250). [ABSTRACT FROM AUTHOR]

Introduction: The frequency of flexible ureteroscopy has increased with the introduction of improved instrumentation. Ureteroscopes allow increased endoscopic access to the ureter and kidney. However, maintenance and repair of scopes may increase the total procedure expense. Methods: In 3 years (8/2011-7/2014), 655 flexible ureteroscopies were performed at a single-specialty, urology, ambulatory surgery center. Procedures were performed by 26 board-certified urologists using four Olympus URF P5 flexible ureteroscopes. The instruments were handled by a single team and sterilized through the STERIS System E1. Repairs were performed by the manufacturer on an as needed basis. Patient records were reviewed to determine the preoperative diagnosis, operative time, location and size of the stone, and use of laser or ureteral sheath. The occurrence, nature of flexible ureteroscope damage, and cost of repairs were evaluated. Results: Of the ureteroscopies performed, 78% was for the treatment of calculi (50.1% in the kidney). Mean stone size was 8.5 ± 0.2 mm, with larger stones (11 mm) located in the kidney. The flexible ureteroscope was advanced over a guidewire (88% of cases); a laser fiber was introduced in 70%, and a ureteral sheath was used in 13.4%. Mean procedure time was 40 minutes. The most common reasons for ureteroscope repair were cloudy lens (16 repairs) and broken optic fibers (9 repairs). There were 31 repairs during the study period (average 21 cases per repair). Flexible ureteroscopes were out of service for an average of 11 days per repair (range 3-20). The total cost of repairs was $233,150 or ∼$7521 per repair. The average repair cost per flexible ureteroscopy performed was $355. Conclusions: Expenses associated with instrument repair can significantly impact a procedure's net revenue, thus efforts should be made to minimize instrument breakage. The expense of repairing a flexible ureteroscope per procedure can be significant and needs to be considered when pricing this procedure. [ABSTRACT FROM AUTHOR]

The article discusses a study on the effect of slowing the delivery rate of shock wave lithotripsy (SWL), a standard treatment for urinary calculi, on stone-free outcome and cost of treatment. It is reported that a change in the technique to slow this rate has improved treatment efficacy. A single lithotripter was used by over 20 urologists at an independent urology surgery center to treat a cohort of 1,745 consecutive cases. It also notes an improvement in the quality of patient care by slowing the said rate.